EP 2799451 A1 20141105 - Generation and profiling of fully human HuCAL GOLD®-derived therapeutic antibodies specific for human CD38
Title (en)
Generation and profiling of fully human HuCAL GOLD®-derived therapeutic antibodies specific for human CD38
Title (de)
Gewinnung und Profiling von vollständig humanen, von HUCAL-Gold(RTM)-abgeleiteten therapeutischen, für humanes CD38 spezifischen Antikörpern
Title (fr)
Production et profilage d'anticorps thérapeutiques dérivés de la technologie Hucal gold(rtm) entièrement humains spécifiques à la protéine humaine cd38
Publication
Application
Priority
- US 68377205 P 20050524
- US 70600405 P 20050808
- EP 06761936 A 20060524
Abstract (en)
The invention pertains to a human or humanized anti-CD38 antibody or functional fragment thereof for use in a method of treating a tumor disease, in particular a haematological disease, by inducing specific killing of tumor cells that express CD38 by CD38 cross-linking. The antibody for use according to the invention include an antibody characterized by a variable heavy chain having the amino acid sequence of SEQ ID NO:6 and a variable light chain having the amino acid sequence of SEQ ID NO:14, an antibody characterized a variable heavy chain having the amino acid sequence of SEQ ID NO:5 and a variable light chain having the amino acid sequence of SEQ ID NO:13 as well as variants thereof.
IPC 8 full level
C07K 16/28 (2006.01); A61P 35/00 (2006.01)
CPC (source: EP US)
A61P 35/00 (2017.12 - EP); C07K 16/2896 (2013.01 - EP US); A61K 2039/505 (2013.01 - EP US); C07K 2317/21 (2013.01 - EP US); C07K 2317/34 (2013.01 - EP US); C07K 2317/55 (2013.01 - EP US)
Citation (applicant)
- US 61447104 P 20041001
- WO 9708320 A1 19970306 - MORPHOSYS PROTEINOPTIMIERUNG [DE], et al
- US 6300064 B1 20011009 - KNAPPIK ACHIM [DE], et al
- WO 0105950 A2 20010125 - MORPHOSYS AG [DE], et al
- KNAPPIK ET AL., J. MOL. BIOL., vol. 296, 2000, pages 57
- KREBS ET AL., J. IMMUNOL. METHODS., vol. 254, 2001, pages 67
- VIRNEKAS, B.; GE, L.; PLUCKTHUN, A.; SCHNEIDER, K.C.; WELLNHOFER, G.; MORONEY S.E: "Trinucleotide phosphoramidites: ideal reagents for the synthesis of mixed oligonucleotides for random mutagenesis", NUCL. ACIDS RES., vol. 22, 1994, pages 5600
- SAMBROOK, J.; FRITSCH, E. F.; MANIATIS, T.: "Molecular Cloning: A laboratory manual", 1989, COLD SPRING HARBOR LABORATORY PRESS
- AUSUBEL, F. M., BRENT, R., KINGSTON, R. E., MOORE, D. D., SEDMAN, J. G., SMITH, J. A., & STRUHL, K.: "Current Protocols in Molecular Biology", 1995, JOHN WILEY AND SONS
- KHORANA ET AL., J. MOL. BIOL., vol. 72, 1971, pages 209 - 217
- GAIT,: "OLIGONUCLEOTIDE SYNTHESIS", 1984, IRL PRESS
- ALFONSO R. GENNARO,: "REMINGTON'S PHARMACEUTICAL SCIENCES", 1990, MACK PUB. CO., article "chapters 27 and 28,", pages: 484 - 528
- GROSSMAN, H. B., UROL. CLIN. NORTH AMER., vol. 13, 1986, pages 465 - 474
- UNGER, E. C. ET AL., INVEST. RADIOL., vol. 20, 1985, pages 693 - 700
- KHAW, B. A. ET AL., SCIENCE, vol. 209, 1980, pages 295 - 297
- ALFONSO R. GENNARO: "REMINGTON'S PHARMACEUTICAL SCIENCES 18th ed.,", 1990, MACK PUB. CO.
- "Remington's Pharmaceutical Sciences", 1980
- ANTONELLI, A.; BAJ., G.; MARCHETTI., P.; FALLAHI, P.; SURICO, N.; PUPILLI, C.; MALAVASI, F.; FERRANNINI, P.: "Human anti-CD38 autoantibodies raise intracellular calcium and stimulate insulin release in human pancreatic islets", DIABETES, vol. 50, 2001, pages 985 - 991
- AUSIELLO C.M.; URBANI F.; LANDE R.; LA SALA A.; DI CARLO B.; BAJ G.; SURICO N.; HILGERS J.; DEAGLIO S.; FUNARO A.: "Functional topography of discrete domains of human CD38", TISSUE ANTIGENS, vol. 56, no. 6, December 2000 (2000-12-01), pages 539 - 47, XP002395101, DOI: doi:10.1034/j.1399-0039.2000.560608.x
- CHAMOW, S.M.; ZHANG, D.Z.; TAN, X.Y; MATHRE, S.M.; MARSTERS, S.A.; PEERS, D.H.; BYRN, R.A.; ASHKNAZI, A.; JUNGHANS, R.P: "humanized, bispecific immunoadhesin- antibody that retargets CD3+ effectors to kill HIV-1-infected cells", J IMMUNOL., vol. 153, no. 9, 1 November 1994 (1994-11-01), pages 4268 - 80, XP055249056
- DATTAMAJUMDAR, A.K.; JACOBSEN, D.P.; HOOD, L.E; OSMAN, G.E.: "Rapid cloning of rearranged mouse immunoglobulin variable genes", IMMUNOGENTETICS, vol. 43, 1996, pages 141 - 151, XP009171778, DOI: doi:10.1007/BF00176675
- ELLIS J. H.; BARBER, K. A.; TUTT, A.; HALE, C.; LEWIS, A. P.; GLENNIE, M. J.; STEVENSON, G. T.; CROWE, J.: "Engineered anti-CD38 monoclonal antibodies for immunotherapy of multiple myeloma", J. IMMUNOL., vol. 155, 1995, pages 925 - 937, XP002146232
- FERRERO, E.; ORCIANI, M.; VACCA, P.; ORTOLAN, E.; CROVELLA, S.; TITTI, F.; SACCUCCI, F.; MALAVASI, F.: "Characterization and phylogenetic epitope mapping of CD38 ADPR cyclase in the cynomolgus macaque", BMC IMMUNOLOGY, vol. 5, 2004, pages 21, XP021002423, DOI: doi:10.1186/1471-2172-5-21
- FLAVELL, D. J.; BOEHM, D. A.; NOSS, A.; WARNES, S. L.; FLAVELL, S. U: "Therapy of human T-cell acute lymphoblastic leukaemia with a combination of anti-CD7 and anti-CD38- saporin imrnunotoxins is significantly better than therapy with each individual immunotoxin", BR. J. CANCER., vol. 84, 2001, pages 571 - 578, XP002579933
- FUNARO, A.; SPAGNOLI, G.C.; AUSIELLO, C.M.; ALESSIO, M.; ROGGERO, S.; DELIA, D.; ZACCOLO, M.; MALAVASI, F: "Involvement of the multilineage CD38 molecule in a unique pathway of cell activation and proliferation", J. IMMUNOL., vol. 145, 1990, pages 2390 - 2396
- GOLAY, J.; ZAFFARONI; LUISELLA; VACCARI, T.; LAZZARI, M.; BORLERI, G.-M.; BERNASCONI, S.; TEDESCO, F.; RAMBALDI, AL; INTRONA, M.: "Biological response of B lymphoma to anti-CD20 monoclonal antibody in vitro: CD55 and CD59 regulate complement-mediated cell lysis", BLOOD, vol. 95, 2000, pages 3900 - 3908
- HAYASHI, T.; TREON, S.P.; HIDESHIMA, T.; TAI, Y-T.; AKIYAMA, M.; RICHARDSON, R.; CHAUHAN, D.; GREWAL, I.S.; ANDERSON, K.C.: "Recombinant humanized anti-CD40 monoclonal antibody triggers autologous antibody-dependent cell-mediated cytotoxicity against multiple myeloma", BR. J. HEAMATOL., vol. 121, 2003, pages 592 - 596, XP002401140, DOI: doi:10.1046/j.1365-2141.2003.04322.x
- HOSHINO S.; KUKIMOTO I.; KONTANI K.; INOUE S.; KANDA Y.; MALAVASI F.; KATADA T.: "Mapping of the catalytic and epitopic sites of human CD38/NAD+ glycohydrolase to a functional domain in the carboxyl terminus", J IMMUNOL., vol. 158, no. 2, 1997, pages 741 - 7
- JACKSON D.G.; BELL J.I.: "Isolation of a cDNA encoding the human CD38 (T10) molecule, a cell surface glycoprotein with an unusual discontinuous pattern of expression during lymphocyte differentiation", J IMMUNOL., vol. 144, no. 7, 1990, pages 2811 - 5, XP002261701
- KNAPPIK,A.; GE,L.; HONEGGER,A.; PACK,P.; FISCHER,M.; WELLNHOFER,G.; HOESS,A; WOLLE,J.; PLUCKTHUN,A.; VIRNEKAS,B.: "Fully synthetic human combinatorial antibody libraries (HuCAL) based on modular consensus frameworks and CDRs randomized with trinucleotides", J MOL BIOL, vol. 296, 2000, pages 57 - 86, XP004461525, DOI: doi:10.1006/jmbi.1999.3444
- KONO, K.; TAKAHASHI, A.; LCHIHARA, F.; SUGAI, H.; FUJII, H.; MATSUMOTO, Y.: "Impaired antibody-dependent cellular cytotoxicity mediated by Herceptin in patients with gastritic cancer", CANCER RES., vol. 62, 2002, pages 5813 - 5817
- KONOPLEVA M.; ESTROV Z.; ZHAO S.; ANDREEFF M; MEHTA K.: "Ligation of cell surface CD38 protein with agonistic monoclonal antibody induces a cell growth signal in myeloid leukemia cells", J IMMUNOL, vol. 161, no. 9, 1998, pages 4702 - 8, XP055274031
- KREBBER, A.; BORNHAUSER, S.; BURMESTER, J.; HONEGGER, A.; WILLUDA, J.; BOSSARD, H.R.; PLÜCKTHUN, A.: "Reliable cloning of functional antibody variable domains from hybridomas and spleen cell repertoires employing a reengineered phage display system", J. IMM. METH., vol. 201, 1997, pages 35 - 55, XP004050040, DOI: doi:10.1016/S0022-1759(96)00208-6
- KREBS,B.; RAUCHENBERGER,R.; REIFFERT,S.; ROTHE,C.; TESAR,M.; THOMASSEN,E.; CAO,M.; DREIER,T.; FISCHER,D.; HOSSA.: "High-throughput generation and engineering of recombinant human antibodies", J LMMUNOL METHODS, vol. 254, 2001, pages 67 - 84, XP004245443, DOI: doi:10.1016/S0022-1759(01)00398-2
- MALAVASI, F.; CALIGARIS-CAPPIO, F.; MILANESE, C.; DELLABONA, P.; RICHIARDI, P.; CARBONARA, A. O.: "Characterization of a murine monoclonal antibody specific for human early lymphohemopoietic cells", HUM. IMMUNOL., vol. 9, 1984, pages 9 - 20, XP023964782, DOI: doi:10.1016/0198-8859(84)90003-X
- MALONEY, D. G.; SMITH, B.; ROSE, A.: "Rituximab: Mechanism of Action and Resistance", SEM. ONCOL., vol. 29, 2002, pages 2 - 9
- MARCHETTI, P.; ANTONELLI, A.; LUPI, R.; MARSELLI, L.; FALLAHI, P.; NESTI, C.; BAJ, G.; FERRANNINI, E.: "Prolonged in vitro exposure to autoantibodies against CD38 impairs the function and survival of human pancreatic islets", DIABETES, vol. 51, 2002, pages 474 - 477
- MEHTA, K.; OCANAS, L.; MALAVASI, F.; MARKS; J.W.; ROSENBLUM, M.G: "Retinoic acid- induced CD38 antigen as a target for immunotoxin-mediated killing of leukemia cells", MOL. CANCER THER., vol. 3, 2004, pages 345 - 352
- NAMBA, M.; OTSUKI, T.; MORI, M.; TOGAWA, A.; WADA, H.; SUGIHARA, T.; YAWATA, Y.; KIMOTO, T.: "Establishment of five human myeloma cell lines", VITRO CELL DEV. BIOL., vol. 25, 1989, pages 723
- NATA K.; TAKAMURA T.; KARASAWA T.; KUMAGAI T.; HASHIOKA W.; TOHGO A.; YONEKURA H.; TAKASAWA S.; NAKAMURA S.; OKAMOTO H.: "Human gene encoding CD38 (ADP- ribosyl cyclase/cyclic ADP-ribose hydrolase): organization, nucleotide sequence and alternative splicing", GENE, vol. 186, no. 2, 1997, pages 285 - 92, XP004093312, DOI: doi:10.1016/S0378-1119(96)00723-8
- NAUNDORF, S.; PREITHNER, S.; MAYER, P.; LIPPOLD, S.; WOLF, A.; HANAKAM, F.; FICHTNER, 1.; KUFER, P.; RAUM, T.; RIETHMÜLLER, G., INT. J. CANCER, vol. 100, 2002, pages 101 - 110
- PLÜCKTHUN A; PACK P: "New protein engineering approaches to multivalent and bispecific antibody fragments", IMMUNOTECHNOLOGY, vol. 3, no. 2, 1997, pages 83 - 105, XP004126672, DOI: doi:10.1016/S1380-2933(97)00067-5
- RAUCHENBERGER R.; BORGES E.; THOMASSEN-WOLF E.; ROM E.; ADAR R.; YANIV Y.; MALKA M.; CHUMAKOV I.; KOTZER S.; RESNITZKY D.: "Human combinatorial Fab library yielding specific and functional antibodies against the human fibroblast growth factor receptor 3", J BIOL CHEM., vol. 278, no. 40, 2003, pages 38194 - 205, XP002404703, DOI: doi:10.1074/jbc.M303164200
- REFF, M.E.; CARNER, K.; CHAMBERS, K.S.; CHINN, P.C.; LEONARD, J.E.; RAAB, R.; NEWMAN, R.A.; HANNA, N.; ANDERSON, D.R.: "Depletion of B cells in vivo by a chimeric mouse human monoclonal antibody to CD20", BLOOD, vol. 83, 1994, pages 435 - 445
- SANTIN, A.D.; BELLONE, S.; GOKDEN, M.; PALMIERI, M.; DUNN, D.; AGHA, J.; ROMAN, J.J.; HUTCHINS, L.; PECORELLI, S.; O'BRIAN, T.: "Overexpression ofHER-2/Neu in Uterine serous papillary cancer", CL. CANCER RES., vol. 8, 2002, pages 1271 - 1279
- SHINKAWA, T.; NAKAMURA, K.; YAMANE, N.; SHOJI-HOSAKA, E.; KANDA, Y.; SAKURADA, M.; UCHIDA, K.; ANAZAWA, H.; SATOH, M.; YAMASAKI, M: "The absence of fucose but Not the presence of galactose or bisectin N-Acteylglucosamine of human IgGl complex-type oligoscaccharides shows the critical role of enhancing antibody-dependent cellular cytotoxicity", J. BIOL. CHEM., vol. 278, 2003, pages 3466 - 3473
- ZHOU, H.; FISHER, R.J.; PAPAS, T.S.: "Optimization of primer sequences for mouse scFv repertoire display library construction", NUCLEIC ACIDS RES., vol. 22, 1994, pages 888 - 889
Citation (search report)
- [Y] WO 9616990 A1 19960606 - WELLCOME FOUND [GB], et al
- [Y] WO 2005042019 A1 20050512 - UNIV ROCHESTER [US], et al
- [Y] ELLIS JONATHAN H ET AL: "Engineered anti-CD38 monoclonal antibodies for immunotherapy of multiple myeloma", JOURNAL OF IMMUNOLOGY, THE WILLIAMS AND WILKINS CO. BALTIMORE, US, vol. 155, no. 2, 1995, pages 925 - 937, XP002146232, ISSN: 0022-1767
- [Y] STEVENSON F K ET AL: "Preliminary Studies for an Immunotherapy Approach to the Treatment of Human Myeloma Using Chimeric Anti-CD38 Antibody", BLOOD, W.B. SAUNDERS, PHILADELPHIA, VA, US, vol. 77, no. 5, 1 March 1991 (1991-03-01), pages 1071 - 1079, XP000930093, ISSN: 0006-4971
- [Y] TODISCO ELISABETTA ET AL: "CD38 ligation inhibits normal and leukemic myelopoiesis", BLOOD, AMERICAN SOCIETY OF HEMATOLOGY, US, vol. 95, no. 2, 15 January 2000 (2000-01-15), pages 535 - 542, XP002411265, ISSN: 0006-4971
- [Y] KUMAGAI MASA-AKI ET AL: "Ligation of CD38 Suppresses Human B Lymphopoiesis", THE JOURNAL OF EXPERIMENTAL MEDICINE, ROCKEFELLER UNIVERSITY PRESS, US, vol. 181, no. 3, 1 January 1995 (1995-01-01), pages 1101 - 1110, XP002411266, ISSN: 0022-1007, DOI: 10.1084/JEM.181.3.1101
- [Y] MALONEY D G ET AL: "Antibody Therapy for Treatment of Multiple Myeloma", SEMINARS IN HEMATOLOGY, PHILADELPHIA, PA, US, vol. 36, no. 1, SUPPL 3, January 1999 (1999-01-01), pages 30 - 33, XP000857401, ISSN: 0037-1963
- [Y] ZOCCHI ELENA ET AL: "A single protein immunologically identified as CD38 displays NAD+ glycohydrolase, ADP-ribosyl cyclase and cyclic ADP-ribose hydrolase activities at the outer surface of human erythrocytes", BIOCHEMICAL AND BIOPHYSICAL RESEARCH COMMUNICATIONS, vol. 196, no. 3, 1993, pages 1459 - 1465, XP002410154, ISSN: 0006-291X
- [Y] FERRERO ENZA ET AL: "Characterization and phylogenetic epitope mapping of CD38 ADPR cyclase in the cynomolgus macaque", BMC IMMUNOLOGY, vol. 5, September 2004 (2004-09-01), XP002410155, ISSN: 1471-2172
Designated contracting state (EPC)
AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LI LT LU LV MC NL PL PT RO SE SI SK TR
DOCDB simple family (publication)
WO 2006125640 A2 20061130; WO 2006125640 A3 20070412; AR 053489 A1 20070509; EP 1888647 A2 20080220; EP 2799451 A1 20141105; TW 200745162 A 20071216; US 2009123950 A1 20090514
DOCDB simple family (application)
EP 2006004991 W 20060524; AR P060102164 A 20060524; EP 06761936 A 20060524; EP 14164595 A 20060524; TW 95118554 A 20060524; US 92083006 A 20060524